Kornimate/medical-research-clean huggingface dataset:
randomized clinical trial evaluating bp1.3656 versus placebo for alcohol use disorder treatment

Conditions: Alcohol Use Disorder

Summary: a multisite randomized clinical trial evaluating bp1.3656 vs placebo for alcohol use disorder treatment.

proof of concept study evaluating in alcohol use disorder, the ability of psychosocial support in combination with bp1.3656 to reduce alcohol consumption. the study will be a multicenter, randomized, double-blind, placebo-controlled phase ii trial with parallel groups to evaluate the effectiveness and the safety of bp1.3656.

Eligibility criteria:
inclusion criteria: * male or female alcohol use disorder * ages 18-65 * absent or minimal alcohol withdrawal symptoms assessed * 18 kg/m2 ≤ bmi ≤ 35 kg/m2 * excessive alcohol use during the 2 weeks between screening and baseline * voluntarily expressed willingness to participate in the study, understanding protocol procedures and having signed and dated an informed consent prior to the start of protocol required procedures while not intoxicated (bac\<0.05). exclusion criteria: * history of delirium tremens, epilepsy, or withdrawal seizures * clinical depression or suicidality: beck depression inventory (bdi) ≥ 16 and suicidality (item g ≠ 0) * recent illicit drug use, i.e. cannabis, cocaine, amphetamines or opioids * clinically significant cardiovascular, hematologic, severe hepatic impairment * history of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse * physical dependence on sedatives or hypnotics that requires pharmacologically supported detox * receiving ongoing alcohol use disorder medication (e.g. baclofen)
ganciclovir: compassionate use in patients with serious or life-threatening cytomegalovirus infections

Conditions: Cytomegalovirus Infections; HIV Infections

Summary: to provide ganciclovir on a compassionate use basis to immunocompromised patients with serious cytomegalovirus (cmv) infections and to study safety and efficacy in this patient population.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * topical acyclovir. exclusion criteria co-existing condition: patients with the following are excluded: * mild to moderate cytomegalovirus (cmv) infections that fail to satisfy the clinical severity criteria. * transplant where a trial reduction of immunosuppressive drug treatment is not feasible. * congenital or neonatal cmv infections where there is not documented congenital or acquired immunodeficiency. * neutropenia unless it is pre-existing. * thrombocytopenia unless it is pre-existing. concurrent medication: excluded: * other myelosuppressive drugs such as cancer chemotherapy agents, interferon, foscarnet, or nucleoside analogs. patients with the following are excluded: * mild to moderate cytomegalovirus (cmv) infections that fail to satisfy the clinical severity criteria. * transplant where a trial reduction of immunosuppressive drug treatment is not feasible. * congenital or neonatal cmv infections where there is not documented congenital or acquired immunodeficiency. * neutropenia unless it is pre-existing. * thrombocytopenia unless it is pre-existing. patients must be immunocompromised with a serious cytomegalovirus (cmv) infection. this would include pneumonia, gastrointestinal disease, hepatitis, or other organ-specific disease or severe wasting syndrome. patients with pre-existing neutropenia or thrombocytopenia, and immediate life-threatening disease can be included if the investigator believes that delay in starting ganciclovir therapy is not advisable. in such patients, the investigator must advise the patient of the risk of further marrow suppression and the increased risk of infection or bleeding; and the patient must sign an amended informed consent form.

Keywords: aids-related opportunistic infections immune tolerance ganciclovir drugs, investigational cytomegalovirus infections acquired immunodeficiency syndrome
deep learning algorithm for recognition of colonic segments.

Conditions: Colonic Diseases

Summary: the purpose of this study is to develop and validate a deep learning algorithm to realize automatic recognition of colonic segments under conventional colonoscopy. then, evaluate the accuracy this new artificial intelligence(ai) assisted recognition system in clinic practice.

colonoscopy is recommended as a routine examination for colorectal cancer screening. complete inspection of all colon segments is the basis of colonoscopy quality control, and furthermore improves the detection rates of small adenomas. recently, deep learning algorithm based on central neural networks (cnn) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. however, there is still a blank in recognition of anatomic sites, which restricts the realization of ai-aided lesions detection and disease severity scoring. this study aim to train an algorithm to recognize key colonic segments, and testify the accuracy of each segments recognition as compared to endoscopic physicians.

Eligibility criteria:
inclusion criteria: * patients aged 18-70 years undergoing conventional colonoscopy exclusion criteria: * known or suspected bowel obstruction, stricture or perforation * compromised swallowing reflex or mental status * severe chronic renal failure(creatinine clearance \< 30 ml/min) * severe congestive heart failure (new york heart association class iii or iv) * uncontrolled hypertension (systolic blood pressure \> 170 mm hg, diastolic blood pressure \> 100 mm hg) * dehydration * disturbance of electrolytes * pregnancy or lactation * hemodynamically unstable * unable to give informed consent

Keywords: deep learning colonoscopy central neural networks
12-week open-label, phase iiib comparing efficacy and safety of rosuvastatin (crestor™) in combination with ezetimibe

Conditions: Hypercholesterolemia; Coronary Heart Disease; Atherosclerosis

Summary: the purpose of this study is to determine whether treatment of rosuvastatin (crestor™) or simvastatin given as monotherapy or given in combination with ezetimibe, will lower the low density lipoprotein cholesterol (ldl-c) in patients with hypercholesterolaemia and coronary heart disease (chd) or a chd risk equivalent, atherosclerosis or a 10-year chd risk of \>20%


Eligibility criteria:
inclusion criteria: * patients with with hypercholesterolaemia and chd or a chd risk equivalent, clinical evidence of atherosclerosis or a framingham 10-year chd risk score of \>20 * patients will need to sign an informed consent before any visit procedures can be performed, including procedures for the optional genetic research and biomarker studies. * patients must be 18 years or older and will be asked to stop taking any current cholesterol-lowering medications. dietary counselling will be provided which will include an overview of the therapeutic lifestyle change (tlc) diet the patients will be asked to follow exclusion criteria: * use of lipid lowering drugs and other prohibited concomitant medications. history of statin-induced myopathy, or serious hypersensitivity reaction to other hmg-coa reductase inhibitors (statins), including rosuvastatin, simvastatin and/or a history of hypersensitivity to any components of ezetimibe. * patients considered to be unstable by their physician after the following events: a myocardial infarction, recent episode of unstable angina, myocardial revascularisation \[percutaneous transluminal coronary angioplasty (ptca), coronary artery bypass graft (cabg) surgery or another revascularisation procedure\] or a transient ischaemic attack (tia) or stroke and patients awaiting a planned myocardial revascularisation

Keywords: hypercholesterolaemia coronary heart disease (chd) atherosclerosis
application of 3d printing in laparoscopic surgery of liver tumors

Conditions: Liver Cancer; Hepatocellular Carcinoma; Liver Metastases

Summary: to explore the utility of personalized 3d printed liver models in planning and navigating laparoscopic resections.

project goal is to evaluate utility of personalized 3d printed models in preoperative planning and performing laparoscopic liver resections. models will be developed with unique, low-cost approach. project will consist of three overlapping modules/stages evaluating: 1. accuracy of 3d printed liver models compared to computed tomography and standard surface or volume rendering 2. whether 3d printed utilized in planning surgery affects the decision making regarding the surgical plan 3. whether 3d printed models utilized in planning and navigating laparoscopic resections affect perioperative outcomes methodology of developing 3d models is described elsewhere. printed models will be delivered to surgical team at least 5 days prior to the resection. surgery will be performed in both arms according to the department's procedures and surgical oncology guidelines.

Eligibility criteria:
inclusion criteria: * age over 18 * patient qualified to undergo liver tumor resection (either primary of metastatic; both benign and malignant lesions) * quality of imaging (ct or mri or pet (positron emission tomography)/ct) satisfactory to develop 3d models * laparoscopic approach * informed consent exclusion criteria: * open approach * technical limitations to model development * no informed consent

Keywords: 3d printing liver cancer laparoscopic surgery
the role of the vagus nerve in tumor-to-brain communication in lung cancer patients

Conditions: Lung Cancer

Summary: the aim of this study is to measure brain metabolism in patients with lung cancer.fdg uptake in the brain in patients with malignant tumors will be compared to the amount of tracer activity found in patients who have benign pulmonary process. if differences between the brain uptake of fdg in the two groups will be found, further assessment will be performed in order to evaluate if such differences could be attributed and specifically localized to the brain regions innervated by the vagus


Eligibility criteria:
inclusion criteria: * patients with spn referred for routine whole body fdg-pet imaging * patients with nsclc and patients with no evidence of lung cancer on further follow up exclusion criteria: * patients with a clinical history of vagotomy, abdominal surgery. brain tumor, brain trauma or cva. or those with a systemic inflammatory disease
hafai cohort 5 year follow up of patients with femoroacetabular impingement undergoing hip arthroscopy

Conditions: Femoro Acetabular Impingement

Summary: patients included in the hafai cohort will be invited for 5 year follow up.

patients with femoroacetabular impingement will be investigated 5 years after surgery. we will used the copenhagen hip and groin score to evaluate pain, activities of daily living, sport, participation in sport and hip-related quality of life. furthermore, degree of hip osteoarthritis will be evaluated using standing x-rays. last, we will investigate number of re-operations and conversions to total hip replacement.

Eligibility criteria:
inclusion criteria: * included in the hafai cohort exclusion criteria: * non
regulating efficacy and wellness in diabetes

Conditions: Diabetes Type 2; Metabolic Syndrome

Summary: the propose of the study is to test the hypothesis that an eight week program consisting of walking exercise and social cognitive theory based group workshops will increase physical activity adherence six months later in older adults with type 2 diabetes or metabolic syndrome.


Eligibility criteria:
inclusion criteria: * adults between the ages of 50-75 years * individuals diagnosed with type 2 diabetes or metabolic syndrome (presence of 3 of the 5 criteria) * physician consent to participate. exclusion criteria: * below age 50 or above age 75 at the beginning of the intervention * exercising regularly more than twice per week for the last six months * diagnosis of type 1 diabetes mellitus * failing the telephone interview of cognitive status * inability to communicate in english
office-based methadone versus buprenorphine to address retention in medication for opioid use disorder treatment.

Conditions: Opioid Use Disorder

Summary: the purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. this study will also examine factors influencing the implementation of office-based methadone.

this study is a randomized, pragmatic hybrid type 1 effectiveness/implementation multisite (approximately 6 sites) trial to determine whether office-based methadone with pharmacy administration and/or dispensing or buprenorphine (bup) results in greater treatment retention in approximately 600 patients with opioid use disorder (oud). this trial will also identify implementation barriers, facilitators and acceptability at the patient, provider and health-systems level for office-based methadone with pharmacy administration and/or dispensing.

Eligibility criteria:
inclusion criteria * 18 years of age or older; * meet diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) criteria for oud; * are initiating a new moud treatment episode exclusion criteria * have been prescribed (and ingested) or been administered more than 72 hours of moud in the 7 days prior to randomization as a "bridge" to the new oud treatment episode. such moud may include prescribed (and ingested) or administered medically managed withdrawal (aka detoxification). * known contraindication to methadone or bup * unwilling to pursue or continue pre-natal care or pregnancy counseling if determined pregnant by urine human chorionic gonadotropin (hcg) testing at the screening assessment * be actively suicidal or severely cognitively impaired (e.g., dementia, untreated psychosis) precluding informed consent as determined by site clinician * current severe comorbid substance use disorder requiring residential or inpatient treatment services as determined by site clinician * be unable or unwilling to provide reliable locator information including 2 or more contacts in addition to themselves * be unwilling to follow study procedures (e.g., unwilling to receive treatment from site clinician, use the study pharmacy, unwilling to be randomized to bup or methadone, or will be unavailable for the follow-up assessments) including allowing the researchers to access their record in the emr and state's prescription drug monitoring program * have previously enrolled in ctn-0131 * currently enrolled in another research study which will conflict with study procedures * are currently in jail, prison or other overnight facility as required by a court of law or have pending legal action that could prevent participation in study activities * unable to conduct research assessments in english as determined by site pi or their designee.

Keywords: opioid use disorder methadone buprenorphine
role of procalcitonin, c-reactive protein, and wbc count in prediction of colorectal anastomotic leak

Conditions: Anastomotic Leak

Summary: the interest in identifying a biological marker for the early detection of al is growing. such a marker could play a vital role in modern fast-track multimodal protocols, allowing safe and early discharge of patients after colorectal surgery with a low rate of readmission. c-reactive protein (crp) has been identified as a valid parameter for detection of postoperative infectious complications after rectal resection. a serum crp level greater than 12.4 mg/dl on postoperative day (pod) 4 is considered predictive of septic complications. according to a recent analysis, the changes in the trajectory of crp levels might be more beneficial than a snipped point. moreover, the trajectory has a negative predictability of up to 99.3%. another interesting biomarker is procalcitonin (pct), the prohormone of calcitonin, produced by parafollicular c cells in the thyroid. normally, it has a very low plasma concentration in healthy individuals (0.01-0.05 ng/ml), and it increases during severe generalized bacterial, parasitic, or fungal infections, but not in noninfectious inflammatory reactions. procalcitonin has been described as an early, sensitive, and specific marker of sepsis. moreover, the plasma concentration of pct has been used as an early predictor of infection in acute pancreatitis, secondary peritonitis, and infectious complications after thoracic, esophageal, and cardiac surgeries. in addition, elevated white blood cell (wbc) count is associated with al after gastrointestinal surgeries. therefore, this study was conducted to evaluate the utility of crp, pct, and wbc count trajectories, as separate and combined biomarkers for prediction of al after colorectal surgery.


Eligibility criteria:
inclusion criteria: * adult patients of either sex who underwent colorectal surgery entailing an anastomosis exclusion criteria: * patients younger than 18 years * patients with active infection at the time of surgery * patients who had received chemotherapy or radiotherapy * patients on long-term corticosteroid therapy.
functional electrical stimulation during cycling in people with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: neuroscience research that has identified potential for recovery (neuroplasticity) following incomplete sci has changed clinical practice away from compensation strategies towards optimizing recovery. important factors include: repetitive exercise, functional electrical stimulation (fes) and appropriate feedback. the icycle combines repetitive exercise with fes and provides feedback on performance in a virtual cycle race. unlike previous devices, performance in the race is determined only by voluntary effort (i.e. not torque generated by fes plus voluntary effort). in this study with incomplete sci participants we will test the icycle with six inpatients to refine the protocol and make technical improvements. we will then conduct an aba pilot study (n=10) in which a 3g-connected icycle is used in people's own homes. we will compare usual care (a) with icycle exercise (b). changes in neural connectivity (tms evoked emg potentials), muscle strength and walking will be measured as well qualitative analysis of users' views.

background: functional electrical stimulation (fes) cycling can benefit health and may lead to neuroplastic changes following incomplete spinal cord injury (sci). our hypothesis is that greater neuroplastic effects occur when electrical stimulation of peripheral nerves is combined with voluntary drive. in this pilot study, we will investigate the effects of a one-month training programme using a novel device, the icycle, in which voluntary effort (cortical drive) is encouraged by virtual reality biofeedback during fes cycling. methods: eleven participants (c1-t12) with incomplete sci (5 sub-acute; 6 chronic) will be recruited and undergo 12-sessions of icycle training. function will be assessed before and after training using the bilateral isnc-sci motor score neurological (motor) function, oxford power grading, modified ashworth score, spinal cord independence measure, the walking index for spinal cord injury and 10m-walk test. power output will be measured during training.

Eligibility criteria:
inclusion criteria: 1. using a wheelchair for at least two hours per day exclusion criteria: 1. cardiac pacemaker 2. pressure sores or unresolved skin problems 3. unhealed lower limb fractures 4. pregnancy 5. active heterotrophic ossification (lower limbs) 6. severe osteoporosis 7. complex regional pain syndrome 8. metal implants near electrode sites 9. lower limb malignancy 10. t6 and below spinal malignancy 11. uncontrolled autonomic dysreflexia 12. history of knee dislocation/subluxation 13. allergy to electrodes 14. cognitive difficulties 15. severe spasticity (ashworth scale 4 or 5 in muscle groups that would prevent smooth pedalling) or 16. neurological degenerative diseases.

Keywords: functional electrical stimulation cycling virtual reality
the effect of non-surgical periodontal therapy plus doxycycline on hba1c in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus With Periodontal Disease

Summary: aim: the purpose of this study is to investigate the effect of nonsurgical periodontal therapy plus doxycycline on glycemic control in type 2 diabetes mellitus (type 2 dm) patients who have periodontitis. materials and methods: a total of 24 type 2 dm patients with periodontitis will be selected for the study, and randomly divided into two equal groups,who are at least 35 years of age and 16 teeth and type ii diabetes are (at least the last 3 months of diagnosis of diabetes and its fbs more than 110 have), and also with periodontal disease are chronic moderate (at least in three areas attachment level to a depth of 3-4 mm maxillary or mandibular been confirmed by clinical examination and radiographic signs are being); takes place. the initial hba1c patients should be between 7-9 percent over the past three months has changed his medication also found the necessary explanations on how to do that consent, plaque index (pi) by loe \& silness, bleeding on probing (bop) based on carter and barnes (if any bleeding number 1 and its absence is 0), probing depth (pd) and clinical attachment levels (cal) were recorded. "group 1": (12 patients) was treated with oral hygiene instruction, scaling, and root planing, and doxycycline for 15 days; and "group 2": (12 patients) has the same treatment but with placebo, after 12 weeks their periodontal condition and fasting blood sugar (fbs), glycated hemoglobin (hba1c) level, will be reevaluated.

doxycycline downregulates the activity of matrix metalloproteinases (mmps), key destructive enzymes in periodontal disease

Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus type ii (at least 3 months before diagnosis, and a fasting blood sugar level of more than 125 mg/dl) and has periodontal disease is a chronic moderate (has a clinical attachment level of 3-4 mm) peritonitis * minimum of 16 natural teeth, and no periodontal treatment in the prior 6 months, - had a glycated α hemoglobin (hba1c) value between 7- 9 percent at screening * had reported no changes in diabetes medications within the last 3 months were in the care of a physician for their diabetes. exclusion criteria: * pregnancy or lactation * history of allergy to drugs used in the study * smoking * diabetes-related emergency within 30 days ago * use of nonsteroidal anti-inflammatory drugs * or taking low dose daily aspirin (75-325 mg)\\ * use of immunosuppressive medications; antibiotic use * dialysis * risk of bleeding complications * the type of disease periodontal (aggressive) * a history of periodontal treatment in the previous 6 months * orthodontic treatment * using the removal prostheses * extensive dental caries * dental abscesses or infections.